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Atila Biosystems Gets FDA Emergency Use Authorization for SARS-CoV-2 Test

NEW YORK – The US Food and Drug Administration on Friday granted Emergency Use Authorization for Atila Biosystems' SARS-CoV-2 test.

The iAMP COVID-19 Detection Kit, a qualitative real-time RT-PCR test, detects SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swabs. The kit includes the company's primer mix, buffer mix, positive and negative control templates, and the sample collection device, which has fiber swabs, collection tubes, and buffer mix.

According to the Mountain View, California-based company, the test is unique because it can detect SARS-CoV-2 RNA directly from samples without a prior RNA extraction process. The test takes less than two hours for results, the company added. 

Use of the test is limited to high-complexity CLIA-certified labs, the FDA said.